What we offer

To simply survive in today’s fast-changing environment is a success. Shorter product cycles make it impossible to survive without continually developing products and services, and  enhancing teamwork. 

We believe that a company’s success depends on engaged and skilled teamwork – staff working together with the right attitude and the appropriate supportive methods and tools.

We offer a range of services such as:

Analysis and investigations

Is your project going the way you want it to? Is it on time? Is everyone in your project group working in alignment with the same goals? Why are outputs from the manufacturing site not in accordance with plans?

When we carry out an analysis, we undertake a comprehensive overview of the technology, design transfer, organisations and logistics, among other factors, to get to the bottom of any problems. We can also oversee managing the implementation of actions to correct them.

We can support you with reliability projects and root cause analysis of problem. See the following link with the background for reliability tests and why it is important to take the time to make a thorough investigation to catch potential problems before delivery. See link PPT.

Management

When it comes to project management, we can support you with, project management, general management, R&D, project audits, investigations, process development, training, education and mentorship, implementation of tools and methods, as well as risk management, among other areas.

Regulatory Affairs

We believe in reliable, guaranteed product registration.

Regulatory requirements are rapidly changing in the Asia region, with local authorities implementing new requirements for the registration of products and how they are reported. We have all the latest up-to-date information you need, and can support you in registering in local markets, according to their specific regulatory requirements for your products, and via a regulatory compliance plan.

Supplier management and development

We conduct Supplier verification, Quality systems audit, Code of Conduct Audit (assessing worker safety, the work environment etc), Quality control, Product audits and Supplier development where we can support you in the development of your suppliers. Everything from an investigation of the current status to the implementation of new SOPs and education of the personnel.

For the TGA implementation model, please see the PPT

Education

We can take care of all your training needs, including tailor-made specific training sessions for the various personnel divisions in your company.

Topics can include, ISO9001, ISO13485, ISO13471, ISO14001, ISO27001, audit, supplier assessment, LEAN, 6S, risk and project management. We have also a popular concept for DFA/DFM (design for assembly/manufacturing), in which we work together with a project group or line organisation on a real case in your company and train employees in the appropriate methods required.

Operations

Operations excellence applies to many areas. We can train your employees to implement LEAN and 6S methods. We can support you with supplier assessments and evaluations, process development of ISO-standard quality management systems, setting up key performance indicators (KPIs), manufacturing quality control, internal and external audits, and design programmes for the transfer of your existing operations and products to Asia.

Outsourcing
Medical device developers often transfer their product designs to an in-house production facility. There is a growing trend, however, to transfer them to an outside contract manufacturer.

Quality Assurance

We can support your organisation to institute an updated or new quality management system. We are expert in implementing and training staff to meet requirements such as ISO13485, ISO9000, ISO27001, ISO14001 and the Chinese NMPA YY/t 2017. We can make a gap analysis and internal audits of your existing system and come up with appropriate suggestions to achieve your company’s goals. We can analyse your working processes and work together with your personnel further develop those processes. We employ the most modern software tools for SOP administration, training and process development.

Executive coaching

Coaching is probably one of the most—if not the most—individually tailored practices in talent development as it involves a close and confidential relationship between the coach and the person being coached. Meeting one-on-one with senior managers or leaders within an organization the executive coach provides a safe, structured, and trustworthy environment in which to offer support for the individual.

Many coaches have been using the GROW model. GROW stands for goal, current reality, options (or obstacles), and will (or way forward). According to the International Coach Federation (ICF), coaching is defined as a partnership